TheraRadar
Data updated: May 26, 2026

BLOXIVERZ (neostigmine methylsulfate)

Trial Activity: Mature 4 active trials
Other Approved 2013-05-31

Bloxiverz helps patients recover from the effects of muscle-relaxing medications used during surgery. It is used for individuals who have received non-depolarizing neuromuscular blocking agents to help restore their normal muscle control. This medication is essential for reversing the temporary paralysis required for certain surgical procedures.

Source: FDA Label • EXELA PHARMA
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How BLOXIVERZ Works

This drug works by blocking the enzyme that breaks down acetylcholine, leading to higher levels of this neurotransmitter in the body. The increased acetylcholine then competes with surgical blocking agents for the same receptors, which restores the connection between nerves and muscles.

Source: FDA Label

Development Insights

Assiut University conducting 5 trials (8%)
76 indications explored (Broad Platform)
→ neuromuscular blockade (11 trials)
→ anesthesia (6 trials)
→ post-dural puncture headache (4 trials)
1
Indication
--
Phase 3 Trials
12
Years on Market

Details

Status
Prescription
First Approved
2013-05-31
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

EXELA PHARMA
Active Ingredient: NEOSTIGMINE METHYLSULFATE

BLOXIVERZ Approval History

2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
27 FDA actions from 2013 to 2023
Oct 2023 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label
Jan 2021 SUPPL
Label · Labeling
FDA Letter Label
Oct 2015 SUPPL
Label · Labeling
FDA Letter Label

What BLOXIVERZ Treats

1 indications

BLOXIVERZ is approved for 1 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Neuromuscular Blockade
Source: FDA Label

BLOXIVERZ Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

1

Same target(s) AND same indication — head-to-head.

PREVDUO
AZURITY
2023 2 indic.

MoA expansion candidates

3

Same target(s), different indications — where else is this mechanism being explored?

RIVASTIGMINE TARTRATE
ALEMBIC PHARMS
2007 2 indic.
EXELON
Novartis
2000 2 indic.

Indication competitors

2

Same indication, different mechanism — what else might this patient receive?

BRIDION
Merck
2015 1 indic.
REGONOL
Novartis
1973 1 indic.
Unlock 1 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to BLOXIVERZ

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

BRIDION
SUGAMMADEX SODIUM
1 shared
Merck
Shared indications:
Neuromuscular Blockade
PREVDUO
GLYCOPYRROLATE
1 shared
AZURITY
Shared indications:
Neuromuscular Blockade
REGONOL
PYRIDOSTIGMINE BROMIDE
1 shared
Novartis
Shared indications:
Neuromuscular Blockade
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Clinical Trial Registry

64 trials
Trial Sponsor ID Phase Status Title
NCT05887375 2096001 MISP Database number 101357 Ph 4 completed Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery
NCT06513013 TAP in cs using us Ph 2, Ph 3 completed MgSO4 as Adjuvants to Bupivacaine vs Neostigmine in TAP Block in Cesarean Section
NCT05116930 21-009530 Ph 2 recruiting Neostigmine and Glycopyrrolate for the Treatment of Headache After Dural Puncture
NCT07203287 24-0406 Ph 4 recruiting Risk of Acute Complications With Rocuronium vs Cisatracurium in Patients With Chronic Kidney Disease
NCT03111121 results posted 1610312153 Ph 4 completed Use of Sugammadex for Reversal of Paralysis in Microlaryngoscopy
NCT03923556 results posted 18-2707 Ph 4 completed Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade at the End of Kidney Transplantation Surgery
NCT06982092 FMASU MS535/2024 Ph 1 completed Using Diaphragm Ultrasonography, Sugammadex Recovers Diaphragmatic Function More Effectively Than Neostigmine.
NCT03519633 GYN LPS-CUR 2018 Ph 2 completed Role of Curarization During Anesthesia for Laparoscopic Hysterectomy
NCT03679611 Sugammadex results posted 18-5629 Ph 4 completed Impact of Sugammadex vs. Neostigmine Reversal on Post-Operative Recovery and Complications
NCT06729047 04-2024-200988 Ph 1, Ph 2 not yet recruiting Prophylactic Intravenous Injection of Neostigmine Plus Atropine Versus Ketorolac on Post-dural Puncture Headache in Patients Undergoing Infraumbilical Surgeries
NCT05794503 results posted STU-2022-1201 Ph 4 completed Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex
NCT05354466 2203-061-1305 Ph 4 completed Perioperative Respiratory Adverse events_sugammadex
NCT04546672 STIM_Bowel results posted 21895 MISP #60224 Ph 4 completed Sugammadex To IMprove Bowel Function
NCT04130230 2019-3 Ph 2 completed Adjuvant Use of Neostigmine in Sepsis and Septic Shock.
NCT04570150 results posted MISP 59701 Ph 4 completed Optimizing Post-operative Recovery in Bariatric Patients With Obstructive Sleep Apnea Undergoing Outpatient Surgery: A Comparison of Sugammadex and Neostigmine
NCT03939923 results posted 1806161309 Ph 4 completed Role of Sugammadex as Reversal Agent in Patients Extubated Immediately After Isolated Coronary Artery Bypass Grafting Surgery
NCT03513406 STUDY00141829 Ph 3 completed Comparison of Reversal of Neuromuscular Blockade With Sugammadex Versus Neostigmine Plus Glycopyrolate in Patients Undergoing Burn Surgery
NCT05289323 IRB NO: 00012098 SN: 0305408 Ph 4 completed Effect of Intrathecal Neostigmine on Post-dural Puncture Headache.
NCT04364607 MS.19.12.937.R1 Ph 4 completed IM Neostigmine for Accelerating Bladder Emptying After CS by Spinal Anesthesia
NCT05342818 IRC112/04/22 Ph 2 completed Evaluating Neostigmine Effect on Reducing Gastric Residual Volume as Compared With Metoclopramide and Ondansetron
NCT03112993 results posted IRB # 2008066 MISP # 56051. Ph 4 completed Speed of Recovery of Reversal of Neuromuscular Blockade in Geriatric Patients Undergoing Spine Surgery
NCT03322657 results posted 17-764 Ph 4 completed Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular
NCT05066035 2013.3/12 Ph 4 completed Residual Paralysis and Reversal With Routine Neostigmine Versus Half-dose Sugammadex and Routine Neostigmine
NCT02574611 KOR-15-026 Ph 1 withdrawn Use of High Resolution Colonic Manometry in Studying Motility
NCT02256280 DATA INT-91/14 2014-002021-35 Ph 4 terminated A Randomized Double Blind Controlled Trial Comparing Sugammadex and Neostigmine After Thoracic Anesthesia
NCT04332627 B-1910/571-004 Ph 4 completed Comparison of QoR-15 in Laparoscopic Cholecystectomy: Sugammadex vs. Neostigmine
NCT03210376 results posted 2017-0046 NCI-2018-01176 Ph 4 completed Neuromuscular Blockade on Shoulder Pain of Elderly
NCT03138967 results posted 2015-1007 Ph 4 completed Investigation of Sugammadex in Outpatient Urological Procedures
NCT04244097 RCTcompstud MS-273-2019 Ph 2 completed The Effect of Intraperitoneal Bupivacaine Versus Bupivacaine With Neostigmine on Pain in Laparoscopic Cholecystectomy
NCT02909439 results posted 917402-3 Ph 4 completed Quality of Recovery After Reversal With Neostigmine or Sugammadex.
NCT03034577 DEEPBLOCK results posted 2016.343 Ph 4 completed Deep Neuromuscular Block for Laparoscopic Surgery
NCT02861131 results posted MISP #55196 Ph 4 completed The Effect of Sugammadex Versus Neostigmine on Postoperative Pulmonary Complications
NCT02845375 BREATH results posted P16.025 Ph 4 completed Effect of Neuromuscular Blockade and Reversal on Breathing
NCT03944473 Sugammadex 2019-10223 Ph 4 withdrawn Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries
NCT02839668 TIVA/TCI-BC IuliuHatieganu Cluj-Napoca Ph 2 completed The Impact of Intravenous Anaesthesia on Angiogenesis in Patients With Breast Cancer (TIVA/TCI-BC)
NCT03587441 M335 Ph 4 completed Intrathecal Neostigmine for Prevention of PDPH
NCT00847938 NEODEC results posted CHD066-08 Ph 3 completed Comparision of Different Dose of Neostigmine at Advanced Decurarization
NCT03276026 results posted VirtuaHealth Ph 4 terminated A Study to Compare Neostigmine vs Sugammadex in Length of PACU Stay in Patients Undergoing Sleeve Gastrectomy Surgery
NCT02860507 results posted TGH015 Ph 4 completed Study to Determine if Administration of Sugammadex Impacts Hospital Efficiency
NCT03021772 Bier Block Ph 2, Ph 3 completed Neostigmine Versus Dexamethasone as Adjuvants to Lidocaine During Intravenous Local Anesthesia
NCT03248648 IRB00008788 Ph 2, Ph 3 completed Efficacy of Intra-articular Neostigmine Versus Ketamine for Postoperative Analgesia in Arthroscopic Knee Surgery
NCT02327923 IERB/284/014 Ph 4 completed Intraoperative Lidocaine Infusion vs. Esmolol Infusion for Postoperative Analgesia in Laparoscopic Cholecystectomy
NCT01962298 SUDIA results posted EC 13/5/60 2013-001926-25, B300201316844 Ph 3 completed Recovery of Diaphragmatic Function After Neuromuscular Blockade and Sugammadex
NCT00779467 results posted IRB00005917 Ph 1 completed Epidural Neostigmine for Labor Pain
NCT02666014 SHF/FG581S/2013 SHF/FG581S/2013 Ph 3 completed Sugammadex Versus Neostigmine for Postoperative Nausea and Vomiting After Laparoscopic Gynaecological Surgery
NCT02375217 ANES.MA.14 Ph 4 completed "Low Dose Sugammadex Combined With Neostigmine and Glycopyrrolate Versus Full Dose Sugammadex for Reversal of Rocuronium-induced Neuromuscular Blockade: a Cost Saving Strategy"
NCT02390817 wakeup01 Ph 4 completed Effect of Sugammadex for Muscle Motor Response and Awareness in Intraoperative Wakeup
NCT03212495 dexmedetomidine vs neostigmine Ph 2, Ph 3 completed Intra-articular Dexmedetomidine Versus Neostigmine After Knee Arthroscopy (a Comparative Study)
NCT01050543 DANCHEONG results posted P06101 Ph 3 completed Comparison of Sugammadex With Neostigmine as Reversal Agents for Rocuronium at Reappearance of T2 (Study P06101)
NCT01479764 results posted P07981 MK-8616-064 Ph 3 completed Study of Sugammadex Versus Usual Care on Incidence of Residual Blockade at Post Anesthesia Care Unit Admission (P07981)

Showing 50 of 64 trials

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

BLOXIVERZ FDA Label Details

Indications & Usage

FDA Label (PDF)

BLOXIVERZ is indicated for the treatment of Neuromuscular Blockade.

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Data Sources

FDA Approval: NDA204078 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment